Safety and Tolerability Study of Liquid Alpha1 Proteinase Inhibitor (API) in Subjects With Cystic Fibrosis
A Double Blind, Randomized, Placebo Controlled, Single Dose, Phase I Study of the Safety and Tolerability of Alpha1 Proteinase Inhibitor (Human) Inhalation Solution (CR002) in Subjects With Cystic Fibrosis
2 other identifiers
interventional
25
4 countries
11
Brief Summary
Study to assess safety and tolerability of a single dose of study-drug administered to Cystic Fibrosis (CF) patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2011
Shorter than P25 for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 3, 2011
CompletedFirst Posted
Study publicly available on registry
May 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedApril 5, 2012
April 1, 2012
4 months
May 3, 2011
April 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of Adverse events
44 Days (Day -21 to Day 22)
Study Arms (2)
Liquid API
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
A single nominal dose of CR002 (three different dose groups) will be inhaled as an aerosol mist produced by an I-neb Adaptive Aerosol Delivery (AAD) System.
A single nominal dose of Placebo will be inhaled as an aerosol mist produced by an I-neb Adaptive Aerosol Delivery (AAD) System.
Eligibility Criteria
You may qualify if:
- Have a confirmed diagnosis of CF: one or more clinical findings consistent with CF and at least one of the following:
- Sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test OR
- A genotype with two identifiable mutations consistent with CF (∆F508 homozygous or two alleles known to cause a class I, II, or III mutation)
- Have an FEV1 ≥30% of predicted normal as defined by age, gender, and height
You may not qualify if:
- Oxygen saturation \<90%
- Changed in treatment regimen within 2 weeks prior to screening
- Antibiotics regimen change \< 4 weeks before screening
- Persistent colonization with Burkholderia cepacia
- Serum IgA \< 50% of lower level of normal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CSL Behringlead
Study Sites (11)
Site 11
Sofia, Bulgaria
Site 12
Varna, Bulgaria
Site 30
Debrecen, Hungary
Site 24
Bialystok, Poland
Site 22
Gdansk, Poland
Site 21
Poznan, Poland
Site 20
Rabka-Zdrój, Poland
Site 23
Warsaw, Poland
Site 42
Papworth Hospital, United Kingdom
Site 40
Penarth, United Kingdom
Site 41
Southampton, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Program director Clinical R&D
CSL Behring
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2011
First Posted
May 4, 2011
Study Start
April 1, 2011
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
April 5, 2012
Record last verified: 2012-04